CN106535977B

CN106535977B - Guide catheter with crescent shaped channel capable of dye flow

Info

Publication number: CN106535977B
Application number: CN201580019109.2A
Authority: CN
Inventors: 帕特里克·A·哈夫科斯特; 马丁·R·威拉德; 彼得·G·埃德曼; 约翰森·S·斯廷森; 乔尔·N·格罗夫; 小安东尼·F·塔索尼
Original assignee: Boston Scientific Scimed Inc
Current assignee: Boston Scientific Scimed Inc
Priority date: 2014-02-03
Filing date: 2015-01-29
Publication date: 2020-03-31
Anticipated expiration: 2035-01-29
Also published as: CN106535977A; EP3102274A1; WO2015116844A1; EP3102274B1; US20150217085A1; US10029070B2

Abstract

An intravascular catheter (100) is disclosed that includes an elongate shaft (610) bounded by a wall, the shaft (610) including at least one port (112) extending through the wall into a lumen (105). At least one channel (210) may be defined between the polymer layers making up the catheter shaft. The channel extends along at least a portion of the shaft and is in fluid communication with the port. The outer and inner diameters of the conduit may be substantially constant along the length of the conduit.

Description

Guide catheter with crescent shaped channel capable of dye flow

Cross Reference to Related Applications

Priority of united states provisional application serial No. 61/935,159, filed 2014, 2, 3, is claimed in this application according to 35u.s.c. § 119, which is incorporated herein by reference in its entirety.

Technical Field

The present invention relates to medical devices and methods of making and using the same. In particular, the present invention relates to a medical device for providing contrast agents or fluids.

Background

A variety of intracorporeal medical devices have been developed for medical use, such as intravascular use. Some of these instruments include guidewires, catheters, and/or other devices. These devices can be manufactured by and used according to a variety of different manufacturing methods. Each of the known medical devices and methods has certain advantages and certain disadvantages. There is a continuing need to provide alternative medical devices and alternative methods of making and using medical devices.

Disclosure of Invention

An intravascular catheter may have an elongate shaft defined by a wall and having a proximal end, a distal end, and a lumen extending therebetween. The shaft may include a length extending between the proximal and distal ends, and at least one port extends through the wall into the lumen. A first layer may be disposed on the shaft extending from a proximal cover port to a distal end of the shaft. The conduit may include a second layer disposed on the first layer, a third layer disposed on the second layer, and at least one channel defined between the second and third layers. The channel may extend along at least a portion of the shaft and into the port. The channel may extend around the shaft but less than its entire circumference. The outer diameter of the third layer may be substantially constant along the length of the shaft.

Another intravascular catheter may include an elongate shaft having a proximal end, a distal end, and a lumen extending therebetween. The elongated shaft may include an inner liner having walls and defining a cavity. The inner liner may include at least one port extending through the wall into the cavity. The elongated shaft may include a braid disposed over the inner liner, the braid extending over the port. The elongated shaft may further include a first polymer layer disposed on the braid, and a second polymer layer disposed on the first polymer layer. The elongate shaft may further include at least one channel defined between the first and second polymer layers and extending along the elongate shaft and into the port. The inner and outer diameters of the elongate shaft may be substantially constant along the entire length of the shaft.

A method of manufacturing a catheter may include placing a first layer over a mandrel having a proximal region and a distal region, creating at least one port through the first layer. The method may further include placing a braid over the first layer and covering the port, placing a first polymer layer over the braid, and placing a crescent shaped mandrel over the first polymer layer. The distal end of the crescent shaped mandrel may extend through the first polymer layer, the braid, and the port. The method may further include placing a second polymer layer over the crescent shaped mandrel and over the first polymer layer, and reflowing the first and second polymer layers, thereby creating a catheter having substantially constant inner and outer diameters. The method further includes removing the mandrel.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The figures and the detailed description that follow more particularly exemplify these embodiments.

Drawings

The invention may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:

FIG. 1 is a cross-sectional view of a portion of an exemplary guide catheter;

FIG. 2A is a cross-sectional view of a crescent shaped mandrel;

FIG. 2B is a cross-sectional view of the channel formed with the mandrel of FIG. 2A in a compressed configuration;

3A-3G are longitudinal side sectional views illustrating steps of manufacturing an exemplary guide catheter;

FIG. 4 is a cross-sectional view taken through line 4-4 of FIG. 3G;

FIG. 5A is a longitudinal side cross-sectional view of an exemplary mandrel;

FIG. 5B is a longitudinal side cross-sectional view showing a step of manufacturing an exemplary guide tube using the mandrel of FIG. 5A;

FIG. 6A is a longitudinal side cross-sectional view of another exemplary guide catheter;

FIGS. 6B and 6C are partial longitudinal cross-sections of an alternative embodiment of the distal end taken from FIG. 6A;

FIG. 7 is an end view of the distal end of the guiding catheter of FIG. 6A;

FIG. 8 is a cross-sectional view of another exemplary guide catheter;

FIG. 9 is a cross-sectional view of another exemplary guide catheter;

FIG. 10 is a longitudinal side cross-sectional view of another exemplary guide catheter;

FIG. 11 is a longitudinal side cross-sectional view of another exemplary guide catheter;

FIG. 12 is a cross-sectional view taken through line 12-12 of FIG. 11;

FIG. 13A is a partial cross-sectional view of the guide catheter of FIG. 12;

fig. 13B is a partial cross-sectional view of the guide catheter of fig. 13A in a curved configuration.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Detailed Description

The following description should be referenced to the drawings, which are not necessarily to scale, wherein like reference numerals are used to refer to like elements throughout. The detailed description and drawings are intended to illustrate, but not to limit, the claimed invention. Those skilled in the art will recognize that the various elements described and/or illustrated may be arranged in a variety of combinations and configurations without departing from the scope of the present application. The detailed description and drawings show exemplary embodiments of the invention.

Certain terms are defined below and applied unless a different definition is given in the claims or elsewhere in this specification.

All numerical values herein are assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" in the context of numerical values generally refers to a range of numerical values that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" includes numbers that are rounded to the nearest significant figure. Other usage of the term "about" (i.e., in contexts not involving numerical values) can be presumed to have its ordinary and customary meaning as understood by and consistent with the context of the specification, unless otherwise indicated.

The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

In this specification and the appended claims, the singular includes or otherwise indicates singular and plural referents unless the context clearly dictates otherwise. In this specification and the appended claims, the term "or" is generally employed to include "and/or" unless the context clearly dictates otherwise.

It should be noted that references in the specification to "one embodiment," "an embodiment," "another embodiment," or the like, indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, the above phrases are not necessarily referring to the same embodiment. Further, when an embodiment is described as having a particular feature, structure, or characteristic, it will be understood by those skilled in the art that the same may be utilized in other embodiments, whether or not explicitly stated, unless clearly stated to the contrary. That is, the various elements described below, even if not explicitly stated in a particular combination, are considered to be combinable or combinable with each other to form other additional embodiments or to supplement and/or complement the embodiments, as understood by those skilled in the art.

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

Most tool and instrument based catheters have at least one element that may require its maximum profile and the ability to guide the catheter. In addition, visibility is often required by the user and the contrast from the guiding catheter is used to see the location within the patient's vessel while the instrument or tool is within the lumen of the guiding catheter. The largest cross-sectional element of the instrument in use may limit the sufficient flow of contrast agent from the proximal end of the instrument by occupying almost all of the catheter interior space and leaving no space for the flow of contrast agent. The user may either withdraw the instrument from the lumen of the guide catheter to inject the contrast media or use a larger guide catheter for this procedure to allow sufficient contrast media flow. However, larger profile guiding catheters may not be suitable for use in all medical procedures.

Accordingly, it may be beneficial to provide alternative medical devices and alternative methods of manufacturing and using medical devices that address at least some of the above-mentioned problems. Some disclosed embodiments are therefore directed to several alternative designs for medical device structures and assemblies, and several methods of making and using the alternative medical device structures and assemblies.

Some embodiments disclosed herein are directed to catheters based on instruments used in guiding the catheter. By dedicating a small dye flow channel in the design without affecting the inner diameter, outer diameter, or other performance attributes of the medical device, visibility of the device or tool while within the guiding lumen and contrast injection from the guiding catheter is provided.

The present invention addresses at least some of the above-identified problems with the disclosed systems, medical devices, and methods of making medical devices that may be used in a guiding catheter while also allowing a contrast agent to flow to a target site. Some of these embodiments are designed with small channels without affecting the inner diameter, outer diameter, or other performance attributes of the guiding catheter.

The present invention also provides a method of manufacturing a guide catheter including a crescent shaped channel that enables a contrast agent or solution to flow within the guide catheter without changing the inner or outer diameter. During construction of such a guiding catheter, channels can be created within the polymer layer to ensure free flow of contrast from the proximal end of the catheter to the target site at the distal end of the catheter. Various exemplary embodiments are described below with reference to the drawings.

Fig. 1 is a cross-sectional view of a portion of an exemplary guide catheter 100 in accordance with an embodiment of the present invention. The guide catheter 100 includes an elongate shaft (e.g., 610 in fig. 6A) having an inner diameter defined by a wall or liner 110. In the following, the wall and the inner liner 110 may be used interchangeably without changing their meaning and function. The elongate shaft includes a proximal end, a distal end, and a lumen 105 extending therebetween. The elongate shaft has a length extending between a proximal end and a distal end of the elongate shaft. In at least one embodiment, the inner diameter of the elongate shaft can be substantially constant along its length. The shaft may also include at least one port (e.g., port 112 in fig. 3A) extending through liner layer 110 into cavity 105. In some embodiments, inner liner 110 may be formed from a suitable material capable of receiving any therapeutic device that may be inserted through lumen 105. Examples of such materials may include, but are not limited to, Polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or the like. Other materials such as polyamide are also commonly used for inner liner 110.

As shown, the guide catheter 100 may also include a first layer disposed on the lining layer 110. In at least one embodiment, the first layer can include a braid 120 defining a number of gaps. The braid 120 may be disposed on the elongate shaft and may extend from the proximal end of the shaft, covering the port 112, to the distal end. The braid 120 may be made using a suitable biocompatible material, including, but not limited to, stainless steel, aluminum, gold, platinum, titanium, PET, polyvinyl chloride (PVC), polycarbonate, nylon, silk, Polyetheretherketone (PEEK), Liquid Crystal Polymer (LCP), or the like.

The first polymer layer 130 may be disposed on the braid 120. The second polymer layer 140 may be disposed on the first polymer layer 130. First polymer layer 130 and second polymer layer 140 may be made using suitable biocompatible materials that can provide sufficient smoothness to these layers. Examples of such materials may include, but are not limited to, polymers such as polyethylene, polyurethane, silicone, polyether block amide, nylon, polyester, or the like.

Guide catheter 100 may also include at least one channel 210 defined between first polymer layer 130 and second polymer layer 140. In some embodiments, the at least one channel 210 comprises two or more channels spaced apart along the circumference of the elongate shaft. The channel 210 may be crescent shaped. As shown in fig. 1, the cross-section of the channel 210 taken perpendicular to the longitudinal axis of the elongate shaft has a generally crescent-shaped cross-section. In some embodiments, channel 210 may extend along at least a portion of the elongate shaft, through the gap of braid 120, through port 112 in liner 110, and into lumen 105. The at least one channel 210 may extend around the shaft but less than its entire circumference. Fig. 1 shows an embodiment of a guide catheter 100 having two channels 210 spaced on opposite sides of the shaft.

Fig. 2A is an enlarged cross-sectional view of a crescent shaped mandrel 200. The crescent shaped mandrel 200 may be used to create a crescent shaped lumen or channel 210 in the guide catheter 100 of fig. 1. The crescent shaped mandrel 200 may have a highly smooth surface. The crescent shaped mandrel 200 may be coated with a non-stick coating to assist in the extraction of the mandrel from the formed guide catheter 100. In some embodiments, the non-stick coating can be a PTEF coating, for example, a hard coating such as DR-55 (RothGraves, Long Lake, MN). In other embodiments, a release agent may be used to coat the crescent shaped mandrel 200 to assist in its movement. The crescent shaped mandrel 200 may be used to create more than one very fluid channel 210 extending along the guide catheter between the first polymer layer 130 and the second polymer layer 140. At its distal end, channel 210 may pass through first polymer layer 130, braid 120, and inner liner 110, and enter lumen 105 through port 112. The crescent shaped channel 210 may increase the likelihood that a contrast agent, such as a dye, is delivered to the end of the guide catheter 100 even if the inner liner 110 of the guide catheter 100 is completely occluded by the interventional instrument or a component of the interventional instrument.

Fig. 2B illustrates the flattened shape that channel 210 may achieve when catheter 100 is in a curved configuration. Although channel 210 may be compressed when catheter 100 is bent, complete collapse of channel 210 may be prevented even when upper surface 202 is deflected downward. Although the upper surface 202 may contact the lower surface in the middle of the channel 210, the sides remain open due to the shape of the channel, as shown in fig. 2B. In this manner, channel 210 remains open for delivery of contrast media even when catheter 100 is bent and channel 210 is compressed.

Fig. 3A-3G show longitudinal cross-sectional views showing steps of manufacturing an exemplary guide catheter. As shown in fig. 3A, the inner liner 110 is disposed on a mandrel 300. Inner liner 110 may be made using a suitable biocompatible material, metal, or alloy. Examples of suitable biocompatible materials, metals, or alloys can include, but are not limited to, stainless steel, aluminum, gold, platinum, titanium, PTFE (e.g.,

commercially available from DuPont Co.), PET, PVC, polycarbonate, nylon, silk, PEEK, and the like.

At least one port 112 may be cut into the inner liner 110 of the guide catheter 100. Port 112 may be cut using a laser. The at least one port 112 is a bore having a small diameter extending completely through the liner 110. A plurality of ports 112 may be formed in the liner layer 110, and the ports 112 may be staggered along the catheter, as shown in fig. 3A. In other embodiments, port 112 may be created along the length of liner layer 110. In some embodiments, the at least one port 112 includes a plurality of ports 112 that are longitudinally offset and spaced apart along a circumference of the liner 110. The port 112 may be located in any desired area of the catheter 100. In some embodiments, the port 112 may be in the distal region of the catheter 100. In other embodiments, more than one port 112 may be in the proximal region of the catheter 100. In still other embodiments, the plurality of ports 112 may be spaced along the length of the catheter 100. The at least one port 112 may have a suitable shape or size including, but not limited to, circular, rectangular, polygonal, irregular, and the like. For example, at least one port 112 may have an "S" shape extending longitudinally along liner 110. In some embodiments, different shaped ports 112 may be present in the liner layer 110. In one embodiment, at least two ports 112 are created in the liner layer 110 such that the ports 112 are disposed opposite sides from each other and are longitudinally spaced apart, as shown in fig. 3A.

As shown in fig. 3B, braid 120 may be placed over liner layer 110 and cover port 112. The braid 120 may be a mesh structure placed on the inner liner 110. The braid 120 may have a high braid angle and may define diamond shaped gaps. The diamond shaped gaps may be relatively short in the longitudinal direction and relatively wide in the radial direction. The braid gap allows the melted and/or heated polymer stream to pass through the braid 120 such that the braid 120 is embedded within the polymer of the catheter shaft. The diamond shaped braid gaps may allow a crescent shaped mandrel to pass through the braid 120 without disrupting the structure of the braid.

Thereafter, as shown in fig. 3B, a second layer including a first polymer layer 130 may be placed on the braid 120. In some embodiments, multiple extrusions of polymer materials of different stiffness (e.g., 72D-62D-55D) may be provided or arranged on the braid 120, resulting in a catheter tube having different stiffness along its length. Next, more than one crescent shaped mandrel 200 may be placed on the first polymer layer 130, as shown in fig. 3C. The distal end of the crescent shaped mandrel 200 may be inserted through the gap of the braid 120 and through the port 112 in the liner 110. In some embodiments, a locking mechanism may be provided in the mandrel 300 such that the distal tip of the crescent-shaped mandrel 200 may be locked to the mandrel 300. An additional polymeric tubular section of the first polymeric layer 130 may be placed on the braid 120 and then an additional crescent shaped mandrel 200 may be placed on the first polymeric layer 130 proximate the remaining port 112, as shown in fig. 3D. In some embodiments, two crescent shaped mandrels 200 may be placed on the first polymer layer 130 such that the distal end of each crescent shaped mandrel 200 extends through the at least one port 112, as shown in fig. 3E. After all of the crescent-shaped mandrels 200 are placed, additional portions of the first polymer layer 130 are added, which extend along the length of the catheter shaft, as shown in fig. 3E. In one embodiment, first polymer layer 130 may be reflowed on braid 120. The polymer material forming the first polymer layer 130 may be meltedAnd flow in the gaps of the braid 120. Using suitable tools, including but not limited to tube furnace, FEP

Heat shrink tooling, custom reflow air tooling, etc., the polymer material may be heated or reflowed on the braid 120. In some embodiments, each section of the first polymer layer 130 is heated or reflowed on the braid after being added to the catheter.

As shown in fig. 3F, the second polymer layer 140 is placed on the crescent shaped mandrel 200 and on the first polymer layer 130. The first and second polymer layers 130, 140 are reflowed on the crescent shaped mandrel 200, thus creating a conduit having substantially constant inner and outer diameters, as shown in fig. 3F. In at least some embodiments, portions of the guide catheter 100 can also be doped, made of, or otherwise include radiopaque materials.

After the polymer layers 130, 140 are reflow welded, the two mandrels, i.e., the crescent mandrel 200 and the mandrel 300, are removed as shown in fig. 3G, forming the guide catheter 100 having the inner lumen 105 and one or more channels 210. The channel 210 extends along the length of the catheter between the first and second polymer layers 130, 140 and is in fluid communication with the lumen 105 at the port 112. In some embodiments, channel 210 extends from the proximal end of catheter 100 to port 112. In other embodiments, channel 210 has a proximal port (not shown) extending through second polymer layer 140 to the exterior of the catheter at a location proximal to port 112. FIG. 4 is a cross-sectional view taken through line 4-4 of FIG. 3G, showing the passage 210 and the port 112. The channels 210 shown in fig. 4 are alternately shaped channels having a progressively higher degree of curvature of the inner surface than the channels 210 shown in fig. 1-2B.

In some embodiments, the combined thickness of the first polymer layer 130 and the second polymer layer 140 is minimized to achieve a catheter having a desired inner and outer diameter. Half of the total polymer thickness may be used for the first polymer layer 130 and half may be used for the second polymer layer 140. In other embodiments, a greater proportion of the total thickness of polymer desired may be used for the first polymer layer 130, with a thinner polymer layer over the channels 210.

A catheter of between 6 and 10french (fr) can be created having an inner diameter ranging from 0.07 to 0.69 inches (0.1778 to 1.753 centimeters). When multiple channels 210 are created in the catheter 100, the channels 210 may be of the same size, or different sized channels 210 may be created using different sized crescent shaped mandrels 200. In one embodiment, a single channel 210 is created. In other embodiments, two channels 210 are created on opposite sides of the conduit. Other embodiments include creating two channels 210 that are less than 180 degrees apart. The channels 210 may have the ports 112 located at the same longitudinal position, or the ports may be longitudinally spaced. In still other embodiments, three, four, or more channels 210 may be created.

Fig. 5A is a side cross-sectional view of an exemplary mandrel 500. In some embodiments, the mandrel 500 may have at least one recess 510 configured to receive the distal end of the crescent-shaped mandrel 200. As shown, the mandrel 500 includes two longitudinally spaced and radially offset recesses 510. The recess 510 may be used to lock the crescent shaped mandrel 200 in place during manufacturing. As discussed above with reference to fig. 3A-3G, the at least one recess 510 may be used to create more than one port 112 in the liner layer 110 of the guide catheter 100. The ports 112 may be created along the length of the liner layer 110 or only on a distal portion of the liner layer 110. Inner liner 110 may be formed using a suitable biocompatible material, including, but not limited to, TFE, or the like. The recess 510 may be of any suitable shape or size, including: crescent, circular, rectangular, etc. In some embodiments, the recess 510 is shaped to complement the distal end of the crescent shaped mandrel 200. Likewise, the port 112 may have a suitable shape or size, including but not limited to crescent, circular, rectangular, polygonal, "S" shaped, and the like. In one embodiment, there may be different shaped ports along the length of the catheter or on portions of the inner liner 110. As discussed herein, the port 112 may be cut by a laser into the inner liner 110.

Similar to that discussed herein with reference to fig. 3C-3D, fig. 5B is a side cross-sectional view showing a manufacturing step. As described above, the braid 120 may be disposed on the inner liner 110 after the port 112 is cut. The first polymer layer 130 may be placed on the braid 120 and then the distal end of the crescent shaped mandrel 200 may be inserted through the gap of the braid 120, through the port 112 in the liner 110, and into the recess 510. Subsequently, the second polymer layer 140 is placed on the crescent-shaped mandrel 200, and the first polymer layer 130 and the second polymer layer 140 are reflowed on the catheter shaft. The crescent shaped mandrel 200 and mandrel 500 are removed leaving the catheter with the lumen and the channel 210 in fluid communication with the lumen. The densities of the first polymer layer 130 and the second polymer layer 140 may be different.

Fig. 6A is a side cross-sectional view of another exemplary guide catheter 600. In another embodiment, the channel 620 is formed in the guide catheter 600 using components left in place instead of using a crescent shaped mandrel that is removed after assembly. As shown, the guide catheter 600 may include a shaft 610, the shaft 610 including one or more microcatheter channels 620. In this embodiment, the crescent-shaped channel 210 (e.g., as discussed with respect to FIG. 1) is replaced with a micropipe channel 620. Each of the microtube channels 620 may be defined by a very small diameter tube, which may have very thin walls. The microcatheter channel 620 may be made using a suitable material or polymer tube compatible with the bonding process and may contribute to the strength of the laminate of the catheter 600. One or more microcatheter channels 620 may be embedded within guide catheter 600 during the manufacturing process. The microcatheter channel 620 may extend to the distal face 615 of the catheter so that the contrast agent may be released from the distal face 615 of the catheter. In other embodiments, the microcatheter channel 620 may extend to a port (not shown) in fluid communication with the lumen 605 of the catheter 600 so that contrast agent may be released into the lumen 605 of the catheter 600.

Each microtube channel 620 may be filled with more than one spacer or bead 630. Interstitial spaces may be defined between the beads 630 to allow fluid to pass through. The one or more beads 630 may prevent the channel 620 from being completely closed when compressed along a bend in the conduit 600. The beads 630 may have any suitable size or shape, including but not limited to circular, rectangular, saw tooth, polygonal, irregular, etc. In some embodiments, the channels 620 may include beads 630 of the same size and/or shape. In alternative embodiments, the channel 620 may include beads 630 of different sizes and/or shapes. For example, 30% of the beads 630 may exceed half the size of the channel 620, while 30% of the beads 630 may be less than one-fourth the size of the channel 620, and 40% of the beads 630 may be flat, with a length, width, and thickness greater than half the size of the channel 620. The beads 630 may be composed of a suitable polymer that does not melt or flow during the bonding process, such that the shape and size of the beads 630 remain unchanged. The beads 630 may have an irregular shape to create more interstitial spaces between them. More than one bead 630 may each be hollow. In an alternative embodiment, the bead 6310 may be solid. In yet another embodiment, the beads 630 may be porous to allow fluid to pass through them. The beads 630 may be composed of a suitable biocompatible metal or alloy. Beads 630 may remain immobilized within microtube channel 620 such that they do not move as fluid passes through microtube channel 620. In other embodiments, beads 630 may be free floating within the microtube channels 620, with a screen 650 or porous plug 660 disposed within the channels 620 at the distal end face 615. The screen 650 or plug 660 may help retain the beads 630 within the channel 620 when the channel 620 is flushed or when contrast passes through the channel 620. The screen 650 or plug 660 may comprise a foam material having open cells with a size less than or equal to one-half the smallest diameter of the beads 630. Fig. 6B and 6C are partial views of an alternative embodiment, showing only portion 640 from fig. 6A.

A method of filling the channel 620 with beads 630 may include suspending the beads in a slurry. The slurry may consist of a mixture of viscous liquids and beads 630. For example, the beads may be within a slurry of liquid soap, such as dishwashing soap. Next, the slurry may be injected into the channel 620. The distal end of the channel may be temporarily closed such that slurry is contained within and fills the channel 620. Once the channel is filled, the temporary distal closure may be removed. The permanent distal port screen 650 or porous plug 660 may prevent the beads 630 from passing through, but allow the slurry liquid to be flushed out of the channels with a liquid such as water or a solvent. This process may be repeated multiple times until the channel 620 is filled with enough beads 630. The channel containing the beads may then be allowed to dry.

Alternatively, the sol-gel may be introduced into channel 620 and the solids may be allowed to settle out of the gel by precipitation when the conduit is placed horizontally. After settling has occurred, the conduit may be raised to a vertical orientation to allow the liquid portion of the sol-gel to drain and dry. This process may be repeated until the channels are sufficiently filled with beads. Examples of particles or beads deposited from sol-gels may include silicon oxides and titanium oxides.

Another method of filling the channel 620 with beads 630 may be to utilize a supersaturated solution of heated solvent and solute. The channel may be filled with the heated supersaturated solution. The contained solution may be allowed to cool, and the solute may then precipitate to form particles or beads 630. In medical procedures, the precipitate may be selected so as to be less soluble in the solution that will pass through the passage during use of the device; for example, physiological saline solution and radiocontrast agent solution at ambient temperature. Examples of supersaturated solutions and precipitates may include sodium orthophosphate in water. For example, 1.5grams (0.05291 spences) of solute may be dissolved in 100cc of cold water, while 157grams (5.538 spences) of solute may be dissolved in 100cc of hot water. Another example is sodium pyrophosphate in water. 5.41grams (0.1908 spences) of solute is soluble in 100cc of cold water, while 93.11grams (3.284 spences) is soluble in 100cc of hot water. (handbook of CRC chemistry and Physics, 62 nd edition, 1981-1982, CRC Press, pages B148-B150.)

Fig. 7 is an end view of the guide catheter of fig. 6 showing the distal end face 615. As shown, shaft 610 may include more than one microtubular channel 620 spaced along the circumference of catheter 600. The channel 620 may have a screen 650 or plug 660 disposed at the distal end.

Fig. 8 is a cross-sectional view of another exemplary guide catheter 800. As shown, the guide catheter 800 may include a shaft 810. Guide catheter 800 is similar in structure and/or function to guide catheter 100, except that shaft 810 or the channel within shaft 810 may include more than one elongate element or wire 820. Each filament 820 may be a porous member. The filament 820 may be made by a method or process that creates interconnected pores within the filament 820. In one embodiment, the one or more filaments 820 may be made using a suitable porous plastic part, such as a plastic part manufactured by permaplast corporation (fisher-tviel, GA). The filament 820 may extend to a port (not shown) near the distal end of the catheter 800 in fluid communication with the lumen of the catheter 800. In some embodiments, the filament 820 may extend near the distal face 615, and a screen 650 or porous foam plug 660 may be disposed between the distal end of the filament 820 and the distal face 615 of the catheter 800. The screen 650 and plug 660 may help retain the filaments 820 within the channel or within the wall of the catheter 800. In some embodiments, the distal end of the filament 820 may be attached to the inner surface of the channel at the distal face 615. Such attachment may secure the filament 820 and prevent the filament 820 from being dislodged as the contrast agent passes therethrough. The filaments 820 may be attached to the catheter shaft 810 with a medical adhesive.

Fig. 9 is a cross-sectional view of another exemplary guide catheter 900. As shown, the guide catheter 900 may include a shaft 910, the shaft 910 including a porous layer or tube 920 embedded within the catheter wall. The porous tube 920 may be a porous polymer sleeve that communicates with a port (not shown) in fluid communication with the lumen of the guiding catheter 900 near the distal end of the catheter. The perforated tube 920 may be made by a method or process that creates interconnected voids within the perforated tube 920. In one embodiment, the perforated tube 920 may be made using a perforated plastic part of permaplast corporation (Fayetteville, GA).

Fig. 10 is a side cross-sectional view of another exemplary guide catheter 1000. Guide catheter 1000 may include a shaft 1010. The shaft 1010 may include at least one channel pre-filled with contrast 1030. Further, each channel 1020 may include a port 1040 in fluid communication with the cavity 1005 of the shaft 1010. Guide catheter 1000 is similar in structure to guide catheter 100 of fig. 1, except that port 1040 may include a membrane or frangible member 1050 disposed over port 1040 to control movement of contrast 1030 into catheter 1000. For simplicity, the inner liner, braid and polymer layers are not shown. A membrane or frangible member 1050 disposed on the port 1040 can be configured to transition from the first configuration to the second configuration upon application of a predetermined fluid pressure through the channel 1020. In the first configuration, the port 1040 may remain closed, while in the second configuration, the port 1040 may be open. The membrane may transition from the first configuration to the second configuration when sufficient hydraulic pressure is applied to the membrane. The membrane 1050 may be configured to rupture when a predetermined amount of pressure is applied. In other embodiments, the membrane 1050 may have a slit that remains closed when no pressure is applied, but opens when a predetermined amount of pressure is applied. This embodiment allows the membrane 1050 to be opened and closed to provide periodic injections of contrast media during a surgical procedure. In one embodiment, an injection system may be used to apply hydraulic pressure on the membrane. In an exemplary version, the injection system may only need to push the pre-filled contrast 1030 out of the catheter 1000 when the contrast 1030 is to be delivered into a blood vessel of a patient.

The guiding catheter 1000 with the channel 1020 pre-filled with contrast 1030 may allow for faster coating of contrast to a target site adjacent the distal end of the catheter and may deliver the contrast with less pressure. This is because contrast is already at the port and is delivered once the desired pressure ruptures or opens the membrane or frangible member 1050. This configuration may be particularly advantageous when thicker or more viscous contrast agents are used or where a greater amount of contrast agent is required. As with the embodiments discussed above, the plurality of ports 1040 may be longitudinally spaced and radially offset and may be disposed adjacent the distal end of the guide catheter 1000.

The manufacture of the pre-filled catheter 1000 may be in accordance with the discussion with reference to fig. 3A-3G. After the crescent shaped mandrel 200 is removed during manufacture, the channel 1020 of the catheter 1000 may be filled with contrast 1030. Alternatively, the channel 1020 may be filled with contrast media prior to passing the catheter 1000 through the vasculature of the patient. A

Fig. 11 is a side cross-sectional view of another exemplary guide catheter 1100. As shown, the guide catheter 1100 may include a shaft 1110, a channel 1120, and a spacer. The spacer may be an elongated element, such as a filament 1130. The filaments 1130 may be made using a suitable biocompatible material, including, but not limited to, stainless steel, aluminum, platinum, titanium, PET, PVC, polycarbonate, nylon, silk, polyetheretherketone, or the like. The guide catheter 1100 is similar in function and/or structure to the guide catheter 100 as described in fig. 1, except that the channel 120 may include a spacer or wire 1130 having a small diameter. For simplicity, the inner liner, braid and polymer layers are not shown in fig. 11. The spacer or filament 1130 may extend axially through the entire length of the crescent shaped channel 1120. In one embodiment, the spacer or filament 1130 may extend through only a portion of the interior of the catheter 1100. The spacer or wire 1130 may prevent complete collapse and closure of the crescent shaped channel 1120 when the guide catheter 1100 is severely bent. The filaments 1130 may be sized to occupy only a portion of the open space of the channel 1120.

In the manufacturing process as described in fig. 3A-3G, the spacer or filament 1130 may be inserted into a bore in a crescent shaped mandrel (similar to crescent shaped mandrel 200 of fig. 2) so that the crescent shaped mandrel may be moved behind the catheter 1100, but the filament 1130 may be left in place. Alternatively, spacers or filaments 1130 may be inserted into channels 1120 after the mandrel is removed.

Fig. 12 is a cross-sectional view taken through line 12-12 of the guide catheter 1100 shown in fig. 11. The wire 1130 may be disposed axially within the channel 1120 of the guide catheter 1100. The filament 1130 may prevent complete closure of the channel 1120 when the catheter 100 is bent. As with the previous embodiments, a plurality of channels 1120 may be spaced along the circumference of the shaft 1110. The filament 1130 may extend all the way to a port near the distal end of the catheter 1100. Alternatively, filament 1130 may be disposed proximal to the port. A screen or porous plug 1135 may be placed at the distal end of the channel 1120. The distal end 1137 of the filament may be attached to the inner surface of the channel 1120. In some embodiments, adhesive 1139 may be used to attach distal end 1137 to the inner surface of channel 1120. Fig. 13A is a partial cross-sectional view of the guide catheter 1100 from fig. 12 showing one of the channels 1120 in greater detail. The channel 1120 is shown with filaments 1130 in the channel 1120 in an open configuration. In this example, the distal end 1137 of the filament 1130 is shown attached to the inner surface of the channel 1120 with an adhesive 1139. Fig. 13B shows the guide catheter of fig. 13A in a curved configuration with the channel 1120 partially collapsed. If the channel 1120 begins to collapse upon bending of the catheter, the internal filaments 1130 may hold the channel partially open. Thus, even if channel 1120 collapses for a period of time or due to severe bending of catheter 1100, filament 1130 still holds the portion of channel 1120 open and allows fluid to flow through channel 1120.

Materials that can be used for various components of the guide catheter 100 (and/or other devices disclosed herein) can include those materials typically associated with medical devices. For simplicity, the following discussion refers to guide catheter 100. However, this is not intended to limit the instruments and methods described herein, as the discussion may be applied to other similar tubular members and/or components of tubular members disclosed herein.

In some embodiments, the beads 630, the filaments 820, the porous tube 920, or the filaments 1130 are made of a bioabsorbable material. If some of these materials are released from the catheter, the materials will decompose harmlessly into chemicals and minerals already present in the body. Bioabsorbable materials can include polymers such as polyglycolic acid, polylactic acid (PLA), Polyhydroxyalkanoate (PHAs) polycaprolactone, polylactic acid-polyethylene oxide copolymers, cellulose, collagen, chitin, combinations thereof, and the like. Bioabsorbable materials such as magnesium and magnesium alloys may also be used.

The guide catheter 100 and its various components may be made of metal, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations of the above, etc., or other suitable materials. Some demonstrations of suitable polymersExamples may include Polytetrafluoroethylene (PTFE), Ethylene Tetrafluoroethylene (ETFE), Fluorinated Ethylene Propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont

) Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., available from DSM engineering plastics)

) Ether or ester copolymers (e.g., butylene/poly (alkylene ether) phthalate and/or other polyester elastomers, such as those available from DuPont

) Polyamides (e.g. available from Bayer)

Or available from Elf Atochem

) Elastomeric polyamides, polyamide/ether blocks, polyether block amides (PEBA, for example under the trade name

Available), ethylene vinyl acetate copolymer (EVA), silicone, Polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g. ethylene vinyl acetate copolymer), Polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, polyethylene

) Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), Polyetheretherketone (PEEK), Polyimide (PI), Polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyterephthalic acid (for example,

) Polysulfone, nylon 12 (e.g., available from EMS American Grilon)

) Perfluoro (propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVDC), poly (styrene-b-isobutylene-b styrene) (e.g., SIBS and/or SIBS50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer/metal composites thereof, and the like. In certain embodiments, the mixture may include up to about 6% LCP.

Some exemplary examples of suitable metals and metal alloys include stainless steel (e.g., 304V, 304L, and 316LV stainless steel), mild steel, nickel-titanium alloys (e.g., linear elastic and/or superelastic nitinol), other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as

625. UNS: n06022 is as

UNS: n10276 such as

Others

Alloys, etc.), nickel-copper alloys (e.g., UNS: n04400 is as

400、

400、

400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: r30035 is as

Etc.), nickel-molybdenum alloys (e.g., UNS: n10665 is as

Alloy (I)

) Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS: r30003 is as

Etc.), platinum-enriched stainless steel, titanium, combinations thereof, etc., or any other suitable material.

As noted above, among the commercially available nickel-titanium or nitinol alloy families, there is a class designated as "linear elastic" or "non-superelastic", which, while similar to the common shape memory and superelastic varieties, may exhibit different and useful mechanical properties. Linear elastic and/or non-superelastic nitinol differs from superelastic nitinol in that linear elastic and/or non-superelastic nitinol does not exhibit a substantial "superelastic plateau" or "flag region" on its stress/strain curve as does superelastic nitinol. Alternatively, for linear elastic and/or non-superelastic nitinol, as the recoverable strain increases, the stress increases substantially linearly or in some but not necessarily complete linear relationship until elastic deformation occurs, or at least more linearly than the superelastic plateau and/or marker region exhibited by superelastic nitinol. Accordingly, linear elastic and/or non-superelastic nitinol in the sense of the present disclosure may also be defined as "substantially" linear elastic and/or non-superelastic nitinol.

In some cases, linear elastic and/or non-superelastic nitinol may also be distinguished from superelastic nitinol in that linear elastic and/or non-superelastic nitinol may remain substantially elastic (e.g., prior to plastic deformation) when subjected to a stress of about 2-5%, while superelastic nitinol may be subjected to a stress of 8% prior to plastic deformation. Both materials can be distinguished from other linear elastic materials, such as stainless steel (which may also be distinguished by composition), which may only be strained by about 0.2-0.44% prior to plastic deformation.

In certain embodiments, the linear elastic and/or non-superelastic nickel-titanium alloy is an alloy that does not exhibit any martensite/austenite phase transitions detectable by Differential Scanning Calorimetry (DSC) and Dynamic Metal Thermal Analysis (DMTA) analysis over a large temperature range. For example, in certain embodiments, the martensite/austenite phase transformation is not detectable in a linear elastic and/or non-superelastic nickel-titanium alloy in a range from about-60 degrees Celsius (C.) to about 120 degrees Celsius (C.). The mechanical bending properties of these materials are therefore substantially inert over this large temperature range with respect to temperature. In certain embodiments, the mechanical bending properties of the linear elastic and/or non-superelastic nickel titanium alloys at ambient or room temperature are about the same as the mechanical properties at body temperature, e.g., they do not exhibit superelastic plateau and/or marker regions. In other words, the linear elastic and/or non-superelastic nickel-titanium alloy retains its linear elastic and/or non-superelastic properties and/or performance over a wide temperature range.

In certain embodiments, the linear elastic and/or non-superelastic nickel-titanium alloy may contain about 50-60 weight percent nickel, the remainder being substantially titanium. In certain embodiments, the composition is about 54-57 weight percent nickel. An exemplary suitable nickel titanium alloy is FHP-NT alloy commercially available from GUHE CHEMICAL TECHNICAL MATERIALS, Inc., of Shenkanchuan county, Japan. Some examples of nickel titanium alloys are disclosed in U.S. patent nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM^TM(available from Neo-Metrics) and GUM METAL^TM(available from Toyota). In certain other embodiments, superelastic alloys, such as superelastic nitinol, may be used to achieve the desired properties.

In at least some embodiments, portions of the guide catheter 100 can also be made of, incorporated into, or otherwise contain radiopaque material. Radiopaque materials are understood to be materials that are capable of producing relatively bright images on a fluoroscopy screen or other imaging technique during a medical procedure. This relatively bright image helps the user of the guiding catheter 100 to determine his position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and the like. In addition, other radiopaque marker bands and/or coils may also be incorporated into the design of the guide catheter 100 to achieve the same result.

In certain embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is applied to the guiding catheter 100. For example, portions of the device may be made of materials that do not substantially distort the image and create substantial artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they produce artifacts in MRI imaging. In some of these embodiments or others, portions of the guiding catheter 100 may also be made of materials that the MRI equipment can image. Some materials exhibiting such characteristics include, for example, tungsten, cobalt chromium molybdenum alloys (e.g., such as

And waiting for UNS: r30003), nickel cobalt chromium molybdenum alloys (e.g., such as

And waiting for UNS: r30035), nitinol, etc., among other materials.

It should be understood that this invention is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. This may include, to the extent appropriate, any feature of one example embodiment may be used in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. An intravascular catheter, comprising:

an elongate shaft comprising a proximal end, a distal end, and a lumen extending therebetween, the elongate shaft comprising:

an inner liner having a wall and defining a cavity, the inner liner having at least one port extending through the wall into the cavity;

a braid disposed over the inner liner, the braid extending over the port;

a first polymer layer disposed on the braid;

a second polymer layer disposed on the first polymer layer; and

at least one channel defined between first and second polymer layers and extending along the elongate shaft and into the port;

wherein the inner and outer diameters of the elongated shaft are substantially constant along the entire length of the shaft.

2. The catheter of claim 1, wherein a cross-section of the at least one channel taken perpendicular to the longitudinal axis of the shaft has a substantially crescent-shaped cross-section.

3. The catheter of any one of claims 1-2, wherein the at least one channel extends around the shaft but less than its entire circumference.

4. The catheter of any of claims 1-2, wherein at least one of the ports comprises a plurality of ports, wherein the plurality of ports are spaced longitudinally along a region of the shaft.

5. The catheter of any one of claims 1-2, wherein the at least one channel comprises a porous layer.

6. The catheter of any one of claims 1-2, further comprising an elongated element or a plurality of beads disposed longitudinally within the at least one channel.

7. The catheter of any of claims 1-2, further comprising a membrane disposed over at least one of the ports, wherein at least one of the ports is configured to rupture upon application of a predetermined fluid pressure through the at least one channel.

8. A method of manufacturing a catheter, comprising:

placing a first layer on a mandrel having a proximal region and a distal region;

creating at least one port through the first layer;

placing a braid over the first layer and covering the port;

placing a first polymer layer on the braid;

placing a crescent shaped mandrel over the first polymer layer, a distal end of the crescent shaped mandrel extending through the first polymer layer, the braid, and the port;

placing a second polymer layer on the crescent shaped mandrel and on the first polymer layer;

reflowing the first and second polymer layers, thereby creating a conduit having a substantially constant inner and outer diameter; and

and removing the core rod and the crescent core rod.

9. The method of claim 8, wherein creating at least one port comprises creating at least one port having an "S" shape extending longitudinally along the first layer.

10. The method of any of claims 8-9, wherein the mandrel has at least one depression, wherein the at least one port is created on the depression, wherein the distal end of the crescent-shaped mandrel is inserted through the first polymer layer, the braid, and the port until the distal end of the crescent-shaped mandrel remains in the depression.

11. The method of any of claims 8-9, wherein after removing the crescent shaped mandrel, the method further comprises inserting a spacer into the channel formed by the crescent shaped mandrel.

12. The method of claim 11, wherein the spacer comprises an elongated element or a plurality of beads.

13. The method of any of claims 8, 9, and 12, wherein placing the first polymer layer over the braid comprises placing a plurality of polymer tubes over the braid, wherein placing the crescent shaped mandrel comprises placing the crescent shaped mandrel over the polymer tubes proximal to the port and inserting the distal end of the crescent shaped mandrel between adjacent polymer tubes, through the braid and through the port.

14. The method of any of claims 8, 9 and 12, wherein creating at least one port comprises creating a plurality of ports, wherein the plurality of ports are spaced longitudinally along a region of the catheter.

15. The method of any of claims 8, 9, and 12, wherein creating at least one port comprises creating two ports disposed on opposite sides and longitudinally spaced apart, wherein placing the crescent shaped mandrel on the first polymer layer comprises placing two crescent shaped mandrels on the first polymer layer, wherein a distal end of each crescent shaped mandrel extends through a port.